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MRE Consumption and Gut Health

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ClinicalTrials.gov Identifier: NCT02423551
Recruitment Status : Completed
First Posted : April 22, 2015
Last Update Posted : April 16, 2019
Sponsor:
Information provided by (Responsible Party):
James Philip Karl, United States Army Research Institute of Environmental Medicine

Study Description
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Brief Summary:
The objective of this study is to determine the impact of consuming MREs as the sole source of subsistence for 21 days on gut bacteria community composition and gut health. Up to 80 free-living adults will be randomized to consume their usual diet or only MREs for 21 consecutive days. MREs will be provided by the Military Nutrition Division, US Army Research Institute of Environmental Medicine (USARIEM). Fecal, urine and blood samples will be collected periodically before, during and after the intervention to measure gut barrier integrity, gut bacteria community composition, and markers of gut health, inflammation, and nutritional status.

Condition or disease Intervention/treatment Phase
Gastrointestinal Tract Other: MRE Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 71 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Effects of Meal, Ready-to-Eat (MRE) Consumption on Gut Health
Actual Study Start Date : April 2015
Actual Primary Completion Date : February 2017
Actual Study Completion Date : February 2017
Arms and Interventions
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Arm Intervention/treatment
No Intervention: Control
Usual diet
Experimental: MRE
MRE consumption
 Other: MRE
MRE consumption


Outcome Measures
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Primary Outcome Measures :
  1. Change in gut barrier integrity [ Time Frame: Baseline to 10 days, 21 days and 31 days ]
    Urine excretion of saccharide probes; circulating zonulin, intestinal fatty acid binding protein, claudin-3, lipopolysaccharide and GLP2 concentrations


Secondary Outcome Measures :
  1. Change in gut microbiota composition [ Time Frame: Baseline to 10 days, 21 days and 31 days ]
    16S rRNA gene sequencing

  2. Change in C-reactive protein concentrations [ Time Frame: Baseline to 10 days, 21 days and 31 days ]
    Serum C-reactive protein

  3. Change in TNF-alpha concentrations [ Time Frame: Baseline to 10 days, 21 days and 31 days ]
    Serum TNF-alpha

  4. Change in interleukin-6 concentrations [ Time Frame: Baseline to 10 days, 21 days and 31 days ]
    Serum IL-6

  5. Change in lipopolysaccharide concentrations [ Time Frame: Baseline to 10 days, 21 days and 31 days ]
    Plasma LPS

  6. Change in iron status [ Time Frame: Baseline to 10 days, 21 days and 31 days ]
    Blood ferritin, soluble transferrin receptor, hemoglobin, hematocrit

  7. Change in vitamin D status [ Time Frame: Baseline to 10 days, 21 days and 31 days ]
    Blood 25-hydroxyvitamin D, 1,25-dihydroxyvitamin D, parathyroid hormone

  8. Change in B-vitamin status [ Time Frame: Baseline to 10 days, 21 days and 31 days ]
    Blood folate, vitamin B12, homocysteine

  9. Change in nutritional status [ Time Frame: Baseline to 10 days, 21 days and 31 days ]
    Blood prealbumin

  10. Change in calcium absorption [ Time Frame: Baseline to 10 days, 21 days and 31 days ]
    Urine calcium

  11. Change in zinc status [ Time Frame: Baseline to 10 days, 21 days and 31 days ]
    Blood zinc, zinc receptor expression


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 62 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • BMI </= 30

Exclusion Criteria:

  • Use of antiobiotcs within 3 months of study participation
  • Use of pro- or prebiotic supplements within 2 weeks of study participation
  • Vegetarian diets
  • Use of laxatives, stool softeners, or anti-diarrheal medications at least once a week.
  • Fewer than 4 bowel movements, on average, per week
  • History of gastrointestinal disease
  • Colonoscopy within 3 months of study participation
  • Food allergies or aversions or other issues with foods that would preclude MRE consumption, including gluten, milk, nuts, or eggs.
  • Use non-steroidal anti-inflammatory medications (NSAIDs) or antihistamine prescribed by a physician or clinician, or unwillingness to discontinue the use of these substances during the study.
  • Actively trying to lose weight
  • Pregnant or lactating
  • Recent blood donation
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02423551


Locations
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United States, Massachusetts
USARIEM
Natick, Massachusetts, United States, 01760
Sponsors and Collaborators
United States Army Research Institute of Environmental Medicine
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: James Philip Karl, Research Dietitian, United States Army Research Institute of Environmental Medicine
ClinicalTrials.gov Identifier: NCT02423551    
Other Study ID Numbers: 15-12HC
First Posted: April 22, 2015    Key Record Dates
Last Update Posted: April 16, 2019
Last Verified: April 2019
Keywords provided by James Philip Karl, United States Army Research Institute of Environmental Medicine:
Gut microbiota
Intestinal permeability
Gut barrier integrity